A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT05372354

This study evaluates the safety and preliminary effectiveness of CC-92480 in combination with Tazemetostat, BMS-986158, Trametinib, and Dexamethasone for treating RRMM. Eligible participants must have relapsed or refractory MM, documented disease progression, measurable disease, and an ECOG PS of 0 or 1. Participants must adhere to the CC-92480 Pregnancy Prevention Plan.

Patient Parameters

Program Overview

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).

Eligibility Criteria

Inclusion Criteria

  • Relapsed or refractory multiple myeloma (MM) and must:

    1. have documented disease progression during or after their last myeloma therapy
    2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
  • Must have measurable disease

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

  • Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)

Exclusion Criteria

  • Known active or history of central nervous system (CNS) involvement of MM

  • Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.

  • Impaired cardiac function or clinically significant cardiac disease

  • Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)

  • For Part 1: received prior therapy with CC-92480

  • For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib

  • Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment

  • Received any of the following within 14 days prior to initiating study treatment:

    1. Plasmapheresis
    2. Major surgery
    3. Radiation therapy other than local therapy for myeloma associated bone lesions
    4. Use of any systemic anti-myeloma drug therapy
  • Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment

  • COVID-19 vaccine within 14 days prior to C1D1

Other protocol-defined inclusion/exclusion criteria apply

Locations

FACILITYZIPCITYSTATE
UAB Comprehensive Cancer Center35249BirminghamAlabama
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center21287BaltimoreMaryland
Dana-Farber Cancer Institute02215BostonMassachusetts
John Theurer Cancer Center at Hackensack UMC07601HackensackNew Jersey
Memorial Sloan Kettering Cancer Center10021New YorkNew York

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